1. Field of the Invention
The present invention relates generally to hemorrhoid treatment and relief, and more specifically to a comprehensive, integrated treatment regimen and relief of pain and discomfort, including separate compositions that promote healing from inside and outside the body. The compositions of the invention are made from vitamins and plant extracts, and include both a topical application composition and a regimen for oral administration.
2. Description of Related Art
Hemorrhoids, sometimes referred to as piles, is a common affliction among both adults and children. The term refers to varicosities of the veins of the hemorrhoidal plexus, characterized by abnormal dilation, knotting, and tortuosity. They may be complicated by inflammation, clotting, and bleeding. A variety of factors have been implicated in causing hemorrhoids, including excessive strain during defecation, prolonged sitting or standing, constipation, overweight, pregnancy, and the normal aging process. Whatever the cause, however, hemorrhoid sufferers experience pain, itching, and discomfort.
When the hemorrhoidal condition is mild to moderate, a conservative course of treatment will usually include stool softeners (such as increased dietary fiber or psyllium seed), sitz baths, and topical analgesics. While such topical analgesics and stool softeners may relieve the patient's symptomatic complaints, they do not actively attempt to alleviate weakness of the veins and capillaries which may either cause or result from constant or repeated stretching and dilatation of the blood vessels of the hemorrhoidal plexus. A return to the normal strength, elasticity, and permeability of the rectal blood vessels may require the formation of collagen and elastin, a process which may be hindered by free radicals and other oxidants in the blood system which occur with aging, dietary insufficiencies, and disease processes.
The present invention addresses this need with a two part treatment regimen so as to treat the disorder from inside the body and on the outside as well. Accordingly, the invention provides a composition for topical application to hemorrhoids made from plant extracts and vitamins, and oral administration of a second composition containing plant extracts and vitamins. It is the simultaneous treatment inside and outside the body that provides the desired relief from hemorrhoids.
Several patents and publications describe the use of plant extracts and vitamins in formulations for treating or alleviating hemorrhoids, skin conditions, and vascular disorders.
U.S. Pat. No. 4,761,285, issued Aug. 2, 1988 to Vasiliou, et al., describes a composition for the relief and treatment of hemorrhoids made from Leptandra Culver's root, chick peas and grape seeds. The composition may be taken orally or made into a salve by the addition of olive oil. U.S. Pat. No. 5,698,206, issued Dec. 16, 1997 to Becker, et al., discloses a composition for the topical treatment of varicose veins composed of a variety of herbs and including 0.01% by volume vitamin E. The effects of the composition may be enhanced by taking vitamin C orally.
U.S. Pat. No. 4,178,372, issued Dec. 11, 1979 to B. C. Coats, teaches a method of stabilizing aloe vera gel for use in facial skin and cosmetic preparations. U.S. Pat. No. 5,266,318, issued Nov. 30, 1993 to D. Taylor-McCord, describes a topical skin formulation for skin damaged by radiation which contains anthraquinone-free aloe vera gel, allantoin and lavender oil. U.S. Pat. No. 4,767,618, issued Aug. 20, 1988 to Grollier, et al., discloses a composition for the cosmetic treatment of hair or skin having between 5-30% by weight powdered plant particles and a cohesive agent, which may be a solvent, fatty body, thickening agent, emulsifier or an emulsion.
U.S. Pat. No. 4,938,960, issued Jul. 3, 1990 to R. Ismail, describes an agent for the treatment of skin containing a high dose of vitamin E with either a blood circulation promoting agent or a vasodilator, and which may optionally include vitamin C. U.S. Pat. No. 5,470,874, issued Nov. 28, 1995 to S. Lerner, teaches topical application of a preparation which includes ascorbic acid (Vitamin C) and up to 5% proanthocyanidin (pycnogenol) derived from pine bark. U.S. Pat. No. 5,587,149, issued Dec. 24, 1996 to Punto, et al., discloses an emulsion for topical application to the skin packaged in a gelatin capsule which has a first phase including Vitamin C dissolved in polyethylene glycol and a second phase having a silicone oil fluid. One example shows pycnogenol in the first phase and Vitamin E in the second phase.
U.S. Pat. No. 5,804,168, issued Sep. 8, 1998 to H. Murad, describes a pharmaceutical preparation for protection of the skin from UV radiation, preferably for oral administration, having (1) at least one antioxidant, which could be Vitamin C or grape seed extract; (2) at least one anti-inflammatory agent, which could be Vitamin E; and (3) at least one immunity boosting component selected from a variety of herbs. U.S. Pat. No. 5,916,573, issued Jun. 29, 1999 to Spiers, et al., discloses a composition for topical treatment of the skin containing about one to ninety-nine percent grapeseed oil (but not a grapeseed extract, Spiers espousing the theory that proanthocyanidins lose their therapeutic effect when hydrated), a hydrating agent (which may be aloe vera and Vitamin E), and deionized water. The preparation is for moisturizing the skin and protecting the skin against free radicals produced by UV radiation.
U.S. Pat. No. 4,925,871, issued May 15, 1990 to Gabette, et al., teaches a method of treating vascular diseases with proanthocyanidin A2, which is extracted from seeds, branches, or the cortex of a tree. U.S. Pat. No. 5,849,338, issued Dec. 15, 1998 to Richardson, et al., discloses compositions containing magnesium for the treatment of vasoconstriction, the compositions optionally containing Vitamins C and E.
U.S. Pat. No. 4,698,360, issued Oct. 6, 1987 to J. Masquelier, discloses a method of preventing and fighting the harmful biological effect of free radicals by administering the extracted proanthocyanidin content from a plant, specifically maritime pine bark (Pinus maritima), in an amount effective to reduce harmful free radical effect. The extract is taken from pine bark and reduced to a powder which may be administered orally, intravenously, or as an ointment. This composition has been marketed under the trademark name Pycnogenol.RTM., a registered trademark of Horphag Overseas, Ltd.
A regimen of supplements for hemorrhoids is suggested in The Healing Power of Vitamins, Minerals and Herbs, (Readers Digest Association, Ltd., Pleasantville, N.Y., 1999) at pp. 138-139, which includes 1,000 mg Vitamin C, 500 mg of flavonoids, and 150 mg of butcher's broom three times daily. The same work recommends bilberry extract for the pain and burning of hemorrhoids at pp. 244-245. In The Healing Power of Herbs, 2nd ed., M. T. Murray (Prima Publishing, Rockin, Calif., 1995), at pp. 365, 385-86, the herbs gotu kola, grape seed extract, bilberry extract, and the herb butcher's broom in combination with Vitamin C are recommended for hemorrhoids.
None of the above inventions and patents, taken either singly or in combination, is seen to describe the instant invention as claimed.